In Case You Missed It: GlaxoSmithKline Just Had a Phenomenal Week!

Marred by bribery claims, GlaxoSmithKline shareholders may not be aware of how impressive of a week the company had from a regulatory and clinical standpoint.

Apr 18, 2014 at 2:15PM

It may have been a holiday-shortened week, but global pharmaceutical giant GlaxoSmithKline (NYSE:GSK) packed quite the punch with four positive news events bound to excite even the most skeptical Glaxo shareholders.

Of course, Glaxo's week was also marred by allegations in five countries -- Poland, Iraq, Jordan, Lebanon, and China -- that it paid bribes to doctors. This bit of news cast a cloud over Glaxo that simply didn't allow its numerous press releases during the week to come to light. If you were too busy focusing on these allegations, here's what you might have missed. 

Source: GlaxoSmithKline, Flickr.

GlaxoSmithKline's phenomenal week
It all began on Tuesday, when GlaxoSmithKline announced that the Food and Drug Administration had approved its subcutaneous, once-weekly type 2 diabetes therapy Tanzeum as an adjunct to proper diet and exercise. Tanzeum is a GLP-1 receptor agonist that enhances insulin secretion and helps regulate a patients' glycemic balance.

Its approval doesn't come as a huge shock since it was studied in five late-stage trials (HARMONY 1 through 5) and met its primary efficacy endpoint of a reduction in HbA1c levels from baseline compared to the placebo in all of them. Although non-inferiority to Actos was not established in one of the studies, the reduction in HbA1c levels of 0.7% to 0.9% demonstrated more than enough statistical significance to give type 2 diabetics a new therapy beginning in the third quarter, when the injectable therapy is set to launch. 

Yesterday, during mid-afternoon, GlaxoSmithKline announced that its revolutionary COPD treatment Incruse Ellipta had received marketing authorization in Canada -- its first approval for anywhere in the world. GlaxoSmithKline has become an absolute COPD therapy powerhouse, and Incruse Ellipta represents its very first long-acting muscarinic antagonist monotherapy designed as a once-daily long-term maintenance therapy of airflow obstruction associated with COPD. Incruse Ellipta will add revenue right next to its other inhaled COPD therapies Anoro Ellipta and Breo Ellipta which Glaxo and Theravance (NASDAQ:THRX) developed together and had approved last year. This entire lineup of dry-powder inhaled medications is proving easy to use and effective, and it should sustain Glaxo's position as a leading developer of COPD therapies.

But that's not all. In addition to Incruse Ellipta's approval, after the closing bell in the U.S. on Thursday, Glaxo and Genmab announced the FDA's supplemental approval of Arzerra as a first-line treatment for treatment-naive chronic lymphocytic leukemia patients who are deemed unable to have fludarabine-based therapy.

This additional indication comes as no surprise given that the drug received the breakthrough therapy designation in September from the FDA as a first-line treatment in select CLL patients, and was impressive in its phase 3 COMPLEMENT 1 trial.

Source: GlaxoSmithKline. 

That trial led to a decipherable improvement in median progression-free survival to 22.4 months for the Arzerra and chlorambucil arm compared to just 13.1 months for the chlorambucil arm alone. Furthermore, the overall response rate improved to 82% from 69% in the Arzerra intent-to-treat arm with 14% of patients experiencing a complete response compared just 1% in the placebo. And, were that not enough, the median time to response and the duration of response easily favored the Arzerra arm. While sales of the drug have been tame thus far, this expanded approval could allow it the opportunity to hit blockbuster status years down the road.

Lastly, also on Thursday, GlaxoSmithKline and Galapagos announced positive data from a phase 2a dose-ranging study involving its JAK1 inhibitor, GSK2586184, for patients with chronic plague psoriasis. Preliminary results demonstrated that the 400 mg dose met the primary endpoint of achieving a 75% or greater improvement from baseline as week 12 in the Psoriasis Severity Index. The adverse events profile was similar between the placebo and GSK2586184, and Glaxo intends to release additional data from this European study later this year.  

Putting things into perspective
All told, no one's happy with allegations of bribery, as it could eventually lead to a regulatory agency stepping in and reviewing GlaxoSmithKline's practices. But, beyond what I suspect will be a short-term news-driven event, Glaxo is firing on all cylinders when it comes to bringing next-generation therapies down its pipeline. Last year, Glaxo brought six new drugs to market, and it looks well on its way to meeting or exceeding that in 2014. In fact, when the company issued its fourth-quarter results in early February, it told investors to expect about 30 brand innovations and extensions in 2014. 

We often forget that large pharmaceutical companies can have immense growth spurts, and we could be on the verge of seeing one from GlaxoSmithKline thanks to a bevy of new approvals. At a mere 13 times forward earnings, the company isn't particularly expensive, and it should continue to pay out a dividend near 5%. If I were a dividend-seeking income investor looking for growth in the health care sector, I would certainly suggest giving GlaxoSmithKline the time of day and further researching this established big pharma.

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4 in 5 Americans Are Ignoring Buffett's Warning

Don't be one of them.

Jun 12, 2015 at 5:01PM

Admitting fear is difficult.

So you can imagine how shocked I was to find out Warren Buffett recently told a select number of investors about the cutting-edge technology that's keeping him awake at night.

This past May, The Motley Fool sent 8 of its best stock analysts to Omaha, Nebraska to attend the Berkshire Hathaway annual shareholder meeting. CEO Warren Buffett and Vice Chairman Charlie Munger fielded questions for nearly 6 hours.
The catch was: Attendees weren't allowed to record any of it. No audio. No video. 

Our team of analysts wrote down every single word Buffett and Munger uttered. Over 16,000 words. But only two words stood out to me as I read the detailed transcript of the event: "Real threat."

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KPMG advises we're "on the cusp of revolutionary change" coming much "sooner than you think."

Even one legendary MIT professor had to recant his position that the technology was "beyond the capability of computer science." (He recently confessed to The Wall Street Journal that he's now a believer and amazed "how quickly this technology caught on.")

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David Hanson owns shares of Berkshire Hathaway and American Express. The Motley Fool recommends and owns shares of Berkshire Hathaway, Google, and Coca-Cola.We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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